Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Reported: October 5, 2022 Initiated: August 24, 2022 #Z-1778-2022
Product Description
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Reason for Recall
A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 1 unit
- Distribution
- Distributed to one customer located in New York.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.. Recalled by Howmedica Osteonics Corp.. Units affected: 1 unit.
Why was this product recalled? ▼
A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2022. Severity: Moderate. Recall number: Z-1778-2022.
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